Does a weaning protocol facilitate liberation from mechanical ventilation in tracheostomized brain-injured patients?

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Introduction: Although a life-saving intervention, mechanical ventilation is apt to unwanted side-effects and complications and should be interrupted as soon as possible. In acutely brain-injured patients, delaying weaning and liberation from mechanical ventilation increase the rate of ventilator-associated pneumonia, septic complications, and mortality. In neurologic and neurosurgical intubated patients, a systematic assessment of the patient’s potential to be weaned off the ventilator has been demonstrated to reduce the risk of re-intubation following extubation failure, compared to the sole physician’s clinical judgment. Objective: We undertook this multicentre randomized controlled trial to evaluate whether a systematic approach to weaning is superior to the physician’s judgment in preventing weaning failure occurring within 48 hours, in neurologic patients undergoing mechanical ventilation through a tracheotomic cuffed tube. Methods: neurosurgical and neurologic tracheotomized patients receiving mechanical ventilation will be randomized to receive either protocolized weaning protocol (intervention group, IG) or a liberal weaning process according to the attending physicians’ clinical judgment (control group, CG). Although in this last group the decision are left entirely to the discretion of the physicians, all the information collected and recorded for the IG will be also available. The criteria for protocol failure i.e., reconnection to the ventilator, are defined a priori. Patients will be considered successfully weaned if they are not reconnected to the ventilator in the following 48 hours.